HyperphosphatemiaNCT01854437
The Effect of Magnesium Oxide on Plasma Phosphate in Hemodialysis Patients
An observational study of Hyperphosphatemia, run by Shiraz University of Medical Sciences at 1 site in Iran.
Trial summary
Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for control of Hyperphosphatemia are used. The aim of this study was to assess the effect of magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its side effects in hemodialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Hyperphosphatemia
- What is being tested?
- Mg Oxide
- Type of treatment
- Pill or oral medicine
- How many people
- 42 participants
- Where
- 1 siteIran
- Study dates
- Jun 2012to Dec 2012
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: hemodialysis patients
Who may be able to join
- hemodialysis with duration>3 months serum P level >5.5 mg/dl serum Ca>8 mg/dl.
Who cannot join
- Mg level >3 mg/dl
Trial locations and contacts
1 site in 1 country.
About this study
Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for control of Hyperphosphatemia are used. The aim of this study was to assess the effect of magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its side effects in hemodialysis patients.
- Conditions
- Hyperphosphatemia
- Being tested
- Mg Oxide
- Keywords
- mg oxide, hyperphosphatemia, plasma phosphor level
- Medical subject headings
- Hyperphosphatemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mg OxideDrug
Also called (Mg®, 21st Century®)
250 mg orally for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| Mg Oxide | Mg Oxide (Mg®, 21st Century®) 250 mg orally for 4 weeks Receives: Drug: Mg Oxide | |
| placebo | placebo 1 tab TDS |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma phosphate level
Measured: 4 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2013 (estimated)
- Study startJun 2012
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperphosphatemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 42 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- Shiraz University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maryam Pakfetrat, Shiraz University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01854437
- Sponsor's protocol ID
- 1391
- Status last verified
- May 2013
- First submitted
- 4 May 2013
- Last updated
- 15 May 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Magnesium Oxide on Plasma Phosphate in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT01854437
- Acronym / sponsor ID
- 1391
- Conditions
- Hyperphosphatemia
- Keywords
- mg oxide, hyperphosphatemia, plasma phosphor level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Shiraz University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 15 May 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hyperphosphatemia is a common problem in hemodialysis (HD) patients. Different chelators for control of Hyperphosphatemia are used. The aim of this study was to assess the effect of magnesium oxide (Mg Oxide) on the control of serum phosphorus (P) level and evaluation of its side effects in hemodialysis patients.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 4 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mg Oxide | – | Drug: Mg OxideMg Oxide (Mg®, 21st Century®) 250 mg orally for 4 weeks |
| placebo | – | –placebo 1 tab TDS |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- hemodialysis patients
Key inclusion criteria (1 listed)
- hemodialysis with duration>3 months serum P level >5.5 mg/dl serum Ca>8 mg/dl.
Key exclusion criteria (1 listed)
- Mg level >3 mg/dl
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mg OxideAlso: (Mg®, 21st Century®)250 mg orally for 4 weeks | Drug | Mg Oxide |
Primary outcome
plasma phosphate level
Time frame: 4 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperphosphatemia, run by Shiraz University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma phosphate level (time frame: 4 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2013.